Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma
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ClinicalTrials.gov Identifier: NCT00808639 |
Recruitment Status :
Completed
First Posted : December 16, 2008
Results First Posted : May 15, 2014
Last Update Posted : October 24, 2016
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Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Amgen
Information provided by (Responsible Party):
Toni Choueiri, MD, Dana-Farber Cancer Institute
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Tracking Information | ||||
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First Submitted Date ICMJE | December 15, 2008 | |||
First Posted Date ICMJE | December 16, 2008 | |||
Results First Submitted Date ICMJE | January 14, 2014 | |||
Results First Posted Date ICMJE | May 15, 2014 | |||
Last Update Posted Date | October 24, 2016 | |||
Study Start Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Patients Achieving Pathologic Response [ Time Frame: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks) ] Pathological response is defined as down-staging to </=pT1, N0 after chemotherapy with pegfilgrastim support.
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Original Primary Outcome Measures ICMJE |
To estimate the pathologic response of this patient population treated with neoadjuvant chemotherapy and pegfilgrastim followed by radical surgery with curative intent. [ Time Frame: 3 years ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma | |||
Official Title ICMJE | A Phase II Trial of Neoadjuvant Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma | |||
Brief Summary | The purpose of this research study is to test the effectiveness of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in combination with pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial carcinoma. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Dose Dense MVAC
Chemo therapy with methotrexate, vinblastine, Adriamycin, Cisplatin
Interventions:
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Publications * | Choueiri TK, Jacobus S, Bellmunt J, Qu A, Appleman LJ, Tretter C, Bubley GJ, Stack EC, Signoretti S, Walsh M, Steele G, Hirsch M, Sweeney CJ, Taplin ME, Kibel AS, Krajewski KM, Kantoff PW, Ross RW, Rosenberg JE. Neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin with pegfilgrastim support in muscle-invasive urothelial cancer: pathologic, radiologic, and biomarker correlates. J Clin Oncol. 2014 Jun 20;32(18):1889-94. doi: 10.1200/JCO.2013.52.4785. Epub 2014 May 12. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
39 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2016 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00808639 | |||
Other Study ID Numbers ICMJE | 08-208 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Toni Choueiri, MD, Dana-Farber Cancer Institute | |||
Original Responsible Party | Toni Choueiri, MD, Dana-Farber Cancer Instiutte | |||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | September 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |